“GSK knew it was not safe to take Paxil (during pregnancy) but said nothing,” his parents say in a video on YouTube. Now Manie has a broken heart, and a scar that runs down the center of his chest. He holds a sign against his scarred chest. It reads, “Why?”

“How many more babies will suffer,” they ask. “Answer this, GSK, please.”

In September 2005, a study on infants born to women taking antidepressants, including Paxil, during the first trimester of pregnancy, revealed a greater risk for overall birth defects and an increased risks for heart defects specifically. Following the study, GSK updated the PRECAUTIONS subsection of its label for Paxil to include the risk of birth defects, including heart defects.

“Do the benefits outweigh the risks?” Manie’s parents ask.  “No. Never.”

What’s to become of Manie’s broken heart?

Read more of Manie’s story at bigpharmavictim.blogspot.com

Source: YouTube, jiedgi

SOURCE: Paxil and Pregnancy › Parents ask GSK: ‘How many more babies will suffer?’

What Gibson soon realized was that a warning about heart defects in infants born to women who took Paxil during pregnancy was issued the very month her daughter was born.

“I never would have taken the (Paxil) had I been told,” Gibson told a reporter for The Province.

The long, red scar down the middle of her daughter’s chest is a painful reminder of the condition she was unnecessarily born with. She says her daughter’s heart defect has made the little girl prone to infections and stunted her growth.

In 2005, the FDA issued a warning to pregnant women and their doctors to stay away from Paxil because of the increased risk of heart defects in newborns. The agency fell short of banning the medication for pregnant women but stated that it “is advising patients that this drug should usually not be taken during pregnancy.”

The risk of heart defects among newborns is about 1 percent overall. For infants born to women taking Paxil, that number jumps to 1.5 to 2 percent, according to studies cited by the FDA.

SOURCE: Paxil and Pregnancy › Babies born to women taking Paxil at higher risk for heart defects

The lawsuit, filed in Pennsylvania state court, is seeking unspecified damages for failing to warn pregnant women about the risks of taking Paxil.

During the last month of her pregnancy, Vasquez learned, while receiving an ultrasound to determine the sex of her baby, that there was something wrong with his heart.

Since then, Adrian has undergone three open-heart surgeries and now has a pacemaker.

The seriousness of these birth defects is such that, at the very first sign of danger, GSK should have issued a strong warning, said attorney Karen Barth Menzies, who is representing the family.

Adrian will need repeated heart surgeries as he continues to grow and may need artificial replacement valves, and perhaps eventually a heart transplant. His prognosis is unclear, she said.

Menzies added that with 40,000 pregnant women nationwide taking antidepressants, thousands of babies are at risk.

Source: Lawyers USA

SOURCE: Paxil and Pregnancy › Paxil Maker Sued Over Child Born with Severe Birth Defects

FDA is advising patients that this drug should usually not be taken during pregnancy, but for some women who have already been taking Paxil, the benefits of continuing may be greater than the potential risk to the fetus.  Women taking Paxil who are pregnant or plan to become pregnant should talk to their physicians about the potential risks of taking the drug during pregnancy.  Women taking Paxil should not stop taking it without first talking with their physician.

The early results of two studies showed that women who took Paxil during the first three months of pregnancy were about one and a half to two times as likely to have a baby with a heart defect as women who received other antidepressants or women in the general population. Most of the heart defects reported in these studies were atrial and ventricular septal defects (holes in the walls of the chambers of the heart). In general, these types of defects range in severity from those that are minor and may resolve without treatment to those that cause serious symptoms and may need to be repaired surgically.

In one of the studies, the risk of heart defects in babies whose mothers had taken Paxil early in pregnancy was about 2 percent, compared to a 1 percent risk in the whole population. In the other study, the risk of heart defects in babies whose mothers had taken Paxil in the first three months of pregnancy was 1.5 percent, compared to 1 percent in babies whose mothers had taken other antidepressants in the first three months of pregnancy.

FDA has asked the manufacturer, Glaxo Smith Kline (GSK), to change the pregnancy category from C to D, a stronger warning. Category D means that studies in pregnant women (controlled or observational) have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risks to the fetus.

Based on results of the preliminary data, GSK updated the drug’s labeling in September 2005 to add data from one study. As additional data have become available, the label has now been changed to reflect the latest data from the two studies and to change the pregnancy category.

Source: FDA

SOURCE: Paxil and Pregnancy › FDA Advising of Risk of Birth Defects with Paxil

The extent of the heart defects ranged from mild to those that were severe enough to require surgery.

The FDA said that based on the data, it is asking that Paxil’s drug classification be changed from “C” to “D”. Doctors use the classification system to decide whether or not to prescribe a specific drug to a woman who is pregnant.

Despite the warning, the FDA said that Paxil’s benefits may outweigh its risks for certain patients. Paxil is also known by the generic name paroxetine.

The FDA noted that Glaxo (GSK ) had changed its label in September to reflect results from one of the clinical studies. The agency said it now asked the company to update Paxil’s label to now include results from the second study.

In September, Glaxo also sent out letters to health professionals advising of the labeling changes for pregnant women, according to the FDA’s website.

Like many other popular antidepressants, Paxil also carries a warning advising that it can trigger suicidal thoughts in some children and adolescents. The drug is not approved for pediatric use.

Paxil was first approved by the FDA in December 1992.

Source: MarketWatch

SOURCE: Paxil and Pregnancy › FDA strengthens pregnancy warning on Glaxo’s Paxil

The company cited newly analyzed data from a retrospective epidemiologic study of major congenital malformations in infants, saying that “preliminary results suggest an increase in the risk of congenital malformations associated with the use of paroxetine as compared to other antidepressants.”

Changes in the drug’s labeling are being made after consultation with the U.S. Food and Drug Administration (FDA).

Current FDA-approved labeling lists paroxetine as a pregnancy Category C drug. Category C is defined as drugs with “no adequate and well-controlled studies in humans to determine the effect on the fetus.” Current labeling reminds prescribers that paroxetine during pregnancy should be used only if the potential benefit justifies the potential risk.

Information will be added to the product label indicating that of 3,581 pregnant women exposed to paroxetine or other antidepressants during the first trimester, use of paroxetine, compared with other antidepressants, was associated with an “increased risk of overall major congenital malformations.”

Specifically, women who took paroxetine were 2.2 times more likely to give birth to an infant with a major congenital malformation and 2.08 times more likely to give birth to an infant with a cardiovascular malformation than women on other antidepressants. Of 14 infants with a major congenital malformation born to women taking paroxetine, 10 of those with cardiovascular malformations had ventricular septal defects.

The new labeling goes on to note that a separate study based on the Swedish Medical Birth Registry “evaluated 4,291 infants exposed to SSRIs in early pregnancy. This study reported no increased risk for overall major malformations in 708 infants born to women with paroxetine exposure early in pregnancy.”

In the company’s “Dear Healthcare Provider” letter regarding the new labeling, GSK said that “it is important to note that because the GSK study was designed to evaluate the relative risk of congenital malformations in infants born to women exposed to antidepressants, the study did not include a comparison to infants who were not exposed to any antidepressant. Therefore, these data should be viewed within the context of the overall prevalence of congenital malformations in the general population, which is estimated in the U.S. to be approximately 3 percent for any malformation, and approximately 1 percent for cardiovascular malformations alone.”

GSK reviewed other epidemiological studies of SSRI exposure during pregnancy in its “Dear Healthcare Provider” letter, as well as several case-control studies. In addition, it cited the National Birth Defects Prevention Study of infants delivered from 1997 through 2001.

In that study, women who took any SSRI were more likely than those who were not exposed to have an infant with omphalocele.

The strongest effect was reported in that study to be with paroxetine, which accounted for 36 percent of all exposures to an SSRI. Infants born to mothers taking paroxetine during the first trimester were found to be 6.3 times more likely to have an omphalocele compared with infants born to mothers who took no SSRIs. An association was also found between SSRI exposure and infants being born with craniosynostosis.

GSK concluded, “The differences in the results from the available studies and the diversity in type of abnormalities recently reported makes it difficult to definitively conclude a causal relationship for any particular congenital abnormality with paroxetine.”

The company, in cooperation with FDA requests, is conducting additional epidemiologic studies “to more fully understand these preliminary findings.”

SOURCE: Paxil and Pregnancy › New Paxil Labeling Warns Of Birth-Defect Risk